The FDA on September 21, 2022, granted regular approval to RETEVMO® (Selpercatinib) for adult patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) with a REearranged during Transfection (RET) gene fusion, as detected by an FDA-approved test. RETEVMO® is a product of Eli Lilly and Company.
Category: FDA Approvals
RETEVMO® (Selpercatinib)
The FDA on September 21, 2022, granted accelerated approval to RETEVMO® (Selpercatinib) for adult patients with locally advanced or metastatic solid tumors with a REearranged during Transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. RETEVMO® is a product of Eli Lilly and Company.
IMFINZI® (Durvalumab)
The FDA on September 2, 2022, approved IMFINZI® (Durvalumab) in combination with Gemcitabine and Cisplatin for adult patients with locally advanced or metastatic Biliary Tract Cancer (BTC). IMFINZI® is a product of AstraZeneca UK Limited.
IMBRUVICA® (Ibrutinib)
The FDA on August 24, 2022, approved IMBRUVICA® (Ibrutinib) for pediatric patients ≥ 1 year of age with chronic Graft Versus Host Disease (cGVHD) after failure of 1 or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension. IMBRUVICA® is a product of Pharmacyclics LLC.
ENHERTU® (fam-trastuzumab deruxtecan-nxki)
The FDA on August 11, 2022, granted accelerated approval to ENHERTU® (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumors have activating human Epidermal Growth Factor Receptor 2 HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. This is the first drug approved for HER2-mutant NSCLC. ENHERTU® is a product of Daiichi Sankyo, Inc.
TABRECTA® (Capmatinib)
The FDA on August 10, 2022, granted regular approval to TABRECTA® (Capmatinib) for adult patients with metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumors have a mutation leading to Mesenchymal-Epithelial Transition (MET) exon 14 skipping, as detected by an FDA-approved test. TABRECTA® is a product of Novartis Pharmaceuticals Corp.
ENHERTU® (fam-trastuzumab deruxtecan-nxki)
The FDA on August 5, 2022, approved ENHERTU® for adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting, or developed disease recurrence during or within six months of completing adjuvant chemotherapy. ENHERTU® is a product of Daiichi Sankyo, Inc.